Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2013-09-30
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the IASD device
IASD
IASD device implantation
Interventions
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IASD
IASD device implantation
Eligibility Criteria
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Inclusion Criteria
1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
2. Age ≥ 40 years old
3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP \< 20 mm Hg
Exclusion Criteria
1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
2. Fick Cardiac Index \< 2.0 L/min/m2
3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis \>70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (\> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade \>2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
40 Years
ALL
No
Sponsors
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Corvia Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Komtebedde, DVM
Role: STUDY_CHAIR
Corvia Medical
Locations
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The Prince Charles Hospital
Brisbane, , Australia
David Kaye
Melbourne, , Australia
St. Vincent Hospital
Sydney, , Australia
Medizinische Universität Graz
Graz, , Austria
Allgemeines Krankenhaus Univesitäts Kliniken
Vienna, , Austria
OLVZ Aalst
Aalst, , Belgium
Homolka Hospital
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
CHRU de Lille
Lille, , France
CHU de Nantes
Nantes, , France
Hôpital Bichat
Paris, , France
Hôpital La Pitié Salpétrière
Paris, , France
Hôpital Rangueil
Toulouse, , France
Universitatklinikum Duseldorf
Düsseldorf, , Germany
Georg-August-Universitat
Göttingen, , Germany
Asklepios Klinik St George
Hamburg, , Germany
Cardiologicum CRC
Hamburg, , Germany
University of Heidelberg
Heidelberg, , Germany
Universtitaät Kliniku Schlewig Holstein
Kiel, , Germany
Klinikum der Universität Munchen
Munich, , Germany
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Fourth Military Hospital
Wroclaw, , Poland
Golden Jubilee Hospital
Glasgow, , United Kingdom
Royal Brompton/Harefield Trust
Harefield, , United Kingdom
King's College
London, , United Kingdom
Countries
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References
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Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.
Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.
Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.
Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.
Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.
Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.
Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.
Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.
Other Identifiers
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2013-01
Identifier Type: -
Identifier Source: org_study_id
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